This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 399
Type: Topic Contributed
Date/Time: Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
Sponsor: Section on Statistical Consulting
Abstract - #308932
Title: The Bureaucracy of Translational Research: Regulatory Challenges Facing the Consulting Statistician
Author(s): Christopher J. Swearingen*+ and Todd G. Nick
Companies: University of Arkansas for Medical Sciences and University of Arkansas for Medical Sciences
Address: Pediatrics Biostatistics Program, Little Rock, AR, 72202,
Keywords: statistical consultation ; CTSA ; IRB ; translational research
Abstract:

The Clinical and Translational Science Award (CTSA) program was initiated by the National Institutes of Health (NIH) in 2006, creating a research initiative with a stated aim to "reduce the time it takes for laboratory discoveries to become treatments for patients". Clinical studies within this framework are usually preliminary, establishing an intervention's feasibility and/or safety. Consulting biostatisticians are challenged by these translational studies to balance broader statistical design criteria while maintaining moderate clinical inference. However, Institutional Review Board (IRB) evaluates all human subject research with the same scrutiny regardless of where it falls in the "march of science." This talk will highlight the regulatory challenges facing translational research collaboration, examining current efforts of CTSA sites to streamline protocol development and approval.


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